Medical Device Recall: GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a pa
Xcision Medical Systems, LLC · November 30, 2023
Reason for Recall
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Product Description
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Distribution
Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
States Affected
NATIONWIDE
Quantity Affected
4 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0750-2024
Status: ongoing
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